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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Comprehensive/Linked-Registry Based Surv.


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General
Application Number P100040 S012/ PAS002
Study Name OSB Lead-Comprehensive/Linked-Registry Based Surv.
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description The purpose of this surveillance project, using the Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) registry, will be to obtain data that can be used to refine the selection of and treatment strategy for patients with Type B aortic dissections managed through endovascular graft repair. Data will also be evaluated to identify any signals of device-specific safety or effectiveness issues. This project will be used to establish performance goals for future studies.

Specifically, the project will evaluate the short- and long-term clinical performance of endovascular grafts for the treatment of Type B thoracic aortic dissection, following premarket approval.

This is a cohort study of patients entered into the VQI registry, treated for Type B thoracic aortic dissection. The project will be comprised of (1) a cohort of patients followed through five years post-implant procedure (this will include a sub-cohort of the 1-year cohort); and (2) a cohort of all-comers followed through one year post-implant procedure.
Study Population Description Two surveillance arms:

a. Five (5)-year cohort: Data will be captured on a minimum of 200 chronic and 200 acute patients with Device Technical Success, and treated at centers agreeing to participate in the surveillance project through the VQI registry. Retrospective enrollment will be allowed for patients treated on or after September 10, 2013 (date of first device approval).

b. One (1)-year: Standard VQI data will be captured on all-comers to the

VQI registry during the specified enrollment period.



Inclusion criteria:

?Patients diagnosed with classic ?double-barrel? Type B thoracic aortic dissection and an identifiable intimal flap, with visible contrast enhancement in the false lumen that are treated with endovascular grafts at centers participating in the VQI registry.

?For the 5-year cohort, subjects will be considered enrolled in the study after arterial cut-down and introduction of the endovascular graft. Data will be collected for unsuccessfully implanted patients through their in-hospital stay.



Exclusion criteria:

?Medial disruption with formation of intramural hematoma/hemorrhage

?Plaque rupture leading to aortic ulceration, penetrating aortic atherosclerotic ulcer with surrounding hematoma, usually subadventitial

?Iatrogenic and traumatic dissection

Sample Size Five (5)-year cohort:

The Professional Societies estimated the 5-year incidence of dissection- related mortality as 10% for acute dissections and 15-20% for chronic dissections.



Separately for acute and chronic dissections:

Assuming a 5-year proportion of 10%, a sample size of 200 acute patients will provide 95% confidence interval width of 5.84 - 14.16 and

assuming 20% incidence of dissection-related mortality, 200 chronic patients will provide confidence interval width of 14.46 - 25.54.



Each participating manufacturer will enroll a minimum of 60 acute and

60 chronic dissection patients for the 5-year cohort treated with their

final device design. Patient enrollment will continue until 200 acute patients and 200 chronic patients are enrolled. If the total sample size of

200 patients has been reached for one arm (acute or chronic) of the 5- year surveillance arm, but an individual device has not met the 60 patients minimum required for that arm, enrollment will only continue for that specific device.



One (1)-year cohort

Patient enrollment under this cohort will begin when the thoracic endovascular aortic repair (TEVAR) forms are released and will end after

200 patients have been enrolled.



It is estimated that 10 new patients will be added to the VQI registry every month.

Data Collection Case report forms within the VQI Registry.

Long term follow-up may be enhanced with claims data in the future

Follow-up Visits and Length of Follow-up up to five years


OSB Lead-Comprehensive/Linked-Registry Based Surv. Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
FDA 6 month report 07/23/2014 07/21/2014 On Time
FDA one year report 01/22/2015 01/14/2015 On Time
FDA 18 month report 07/23/2015 07/17/2015 On Time
FDA 2 year report 01/22/2016 01/13/2016 On Time
FDA 3 year report 01/21/2017    
FDA 4 year report 01/21/2018    
FDA 5 year report 01/21/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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